This is all going to be a bit complicated but I’d love to find others who want to have this…rather difficult…debate.
With my regional recurrence and being triple negative I’m nearly at the stage of having run out of treatment options…scary, teary place…
and there in cancer treatment’s armoury is the spectre of a drug called avastin which is an anti cancer drug that attacks a protein in cancer cells called vascular endothelial growth factor (VEGF) There’s a few women on these forums getting it…either as part of trials or on private med insurance…maybe a couple through PCTs. Avastin isn’t yet on the NICE list of approved drugs for advanced breast cancer. It is being used in the US and in other parts of Europe. The NICE equivalent body in the US called the FDA initially voted against licensing avastin last December and then changed its mind in March. Loads of women in the US are gettign avastin…and it seems to be being used particularly for people with triple negative disease. So could this be my wonder drug? The one I should be arguing and battling for??
Trouble is I feel very ambivalent because I’ve read the trial reports form the USA and though the drug shows improvement in what’s known as progression free survuival (PFS) its not been shown to make any significant statistical different to overall survival( OS). Plus avastin has some dody side effects (including death) but then what drug for cancer doesn’t have some dodgy side effects.
I’ve been reading stuff rcently about ‘endpoints’ in breast cancer clinical trials…and the difference between an endpoint which focuses on the amount of time from taking a drug to disease progression and an endpoint about the numbers of people still alive at a given point of time. And I realise thatamong patients here in the UK we don’t often seem to have those discussions about which matters to us. And I can’t, no matter how much I read find out whether progression free survival is the same as what I’d call ‘symptom free survival’ (though there seems to be a concept in trials of HRQQL…health related qulaity of life…which in my book sounds pretty important.)
It is likely that over the coming months we are going to hear more about the avalaibility (or not) of avstin…already I knowthere are women on this site who’ve had to struggle ot get avastin…even when they’ve been prepared to pay for it themselves.
But my dilemma is that I actually don’t quite see avastin as a ‘wonder drug’… its certainly not a new herceptin from what I can make out. It is heartbreaking to have cancer and to know that the drugs which may save people in the future are not perhaps quite here yet. And I just don’t know, cause how can any of us really know, which drugs might actually prove a miracle…I suspect for me there are none. I want to have hope but for me hope is not simply about trying the next drug and the next drug and the next drug irrespective of what clincial trials say. Does anyone else feel like this?
I know this is a very tricky area…I’ve deliberately posted here in current issues rather than in the scondaries forum because I think this issue of clinical trials endpoints matters to us all as breast acncer patients…particularly if we want to be able to have any influence over how the development of drugs goes in future.
Until the mid 90s high dose chemotherapy involving bone marrow transplant (a particularly horrible way to have chemotherapy.) was routinely used in the US and to a lesser extent here or more aggressive breast cancers. It was then found that it gave no overall survival benefits and is not used these days. Is this what will happen to avastin? How do we know. How can we decide? How can we support each other in the different kinds of decisions each of us makes?
Jane
I personally wouldn’t take part in any drug trials because I wouldn’t want to have something that potentially might be worse or no better than the existing treatment. I think I was proved right when that disastrous trial took place with those young men a year or two back. But having said that, someone has to try these things out if any progress is going to be made. I found though that a lot of hospitals jump the gun e.g. with sentinel node biopsy and start using it before the trial is out, and don’t tell you it is still being trialled, at least that’s what barts did, and they used only the dye which has been found to be less accurate than dye plus radioactive tracer. I insisted on extra node sampling.
In conclusion, I think they should be up front about the risks, potential benefits etc. Then whoever tries the treatment can do so in the full knowledge of what it may or may not do. I don’t particularly approve of asking people who won’t be cured of cancer to trial things as I think they shouldn’t be exploited at a time when they may find it difficult to say no. Mind you, someone has to volunteer I suppose. It’s just not going to be me.
Mole
When I have participated in clinical trials, every detail, pros & cons, were pointed out to me beforehand. I was free to stop at any point (and I did stop participating in one trial) and I would have no qualms about considering further trials, indeed I would welcome the chance as I know others in my position (2ndaries) would.
I agree Jane, I don’t think Avastin will be a wonder drug, but it will be a new drug allowing us (hopefully) a year or two extra time while some of the new discoveries you refer to move forward - to clinical trial stage which I hope will be available to us. What I don’t understand is how the addition of new cancer drugs does not extend overall survival? Also, all of the current drugs available to us can have significant side effects (as you say) so I don’t really see that Avastin is so very different in this respect. Who knows, the much mentioned revision of the availabilty of new drugs may have happened by then and we will still be managing to hang on in there by the (very dry and chapped) skin of our teeth. I’m afraid that for me at least, the hope of new drugs just to keep me clinging on will do me for now.
I guess all we can do is respect one anothers’ decisions to go down which ever treatment route we deem best and not to judge.
Jenny.
Hi Jenny
Some cancer drugs do extend overall survival…but the trials in US suggest avastin doesn’t…it just prolongs the period till tumour progression…which is different. Some patient advocates in the USA (NBBC) are concerend about changing the goal posts from overall survival to progression free survival. I agree there may yet be trials which show a different outcome for avastin but think these issues are important to think about. I think there’s an argument for drugs which provide improved quality of life/symptom free survival but I’m not convinced about those that only improve progression free survival though agree it may be nice to think that a drug is ‘working’ even if it subequently fails.
I’m pretty sure I would never participate in a phase 1 trial though admire those who do. (and would do Phase 3.)
I don’t know what I will do about seeking out avastin yet…but whatever I do want it to be informed by evidence…its the way I’ve always approached having cancer and helps me to make sense of what’s happening.
Jane
Hi Jane, (and Jenny and Mole),
Thanks for raising a very relevant question in your usual thoughtful way. I’m sorry you find yourself in this scary and difficult place.
I’m sure I’ve read some other studies where progression free survival was increased but overall survival remained the same - does this mean that once prgression occurs people die faster?! Or am I missing something? Can anybody explain?
Jenny - I liked your point about being perfectly entitled to withdraw from a trial whenever you like, even in the middle. That might help people decide whether to take part in one.
Sorry Jane, no answers. We need a statistician on the site!
All the best
Jacquie
Yes, I should have added, I would do phase iii trials, but not phase i. I think that, like all cancer drugs, Avastin is going to be more suitable for some than others. Some seem to have great results with tumours disappearing (symptom free survival) while others may suffer the more unpleasant side effects and progression etc. Improved diagnostic tools would be a help - but again, some way off in the dim and distant future - so that response could be assessed before embarking on a new drug or treatment.
And your approach is one I (and my onc) recognise, to go in armed with all the info and evidence. It really does make it easier if one understands some of the biology, if not the chemistry of it all. Bah humbug, wish I was doing a different evening class than cancer research.
Jenny.
Can you wait until ASCO in late May? There should be more info coming out then. It is always hard to tell with trials. Perhaps they just haven’t gotten the use of avastin right. Herceptin has a good reputation now, but early on when it was combined with adriamycin it was literally lethal.
On phase I trials, it is important to keep in mind that not all phase I trials are equally risky. The riskiest phase I trials are those of completely new drugs. Some phase I drug trials are actually more like phase I/II trials: they take a drug or drug combo that has worked in another cancer and see whether it can be tolerated by patients with another cancer and whether it seems to be effective in them. The level of risk and prospect of benefit is much higher for drugs that have a proven benefit for some other type of cancer.
I have had some statistical training and would think that failure of overall survival to improve while progression free survival improves would have to mean that there is a shorter time left once progression occurs. The big issue is whether quality of life improves, but how one would get around the placebo effect is a difficult one.
Hi Christine
Thanks for insight on Phase 1 trials. Let us know too if you hear of anything intersting about avastin at ASCO in May.
I suppose the debate I am wanting is about whether if it is the case that a particular drug only improves progression free survival and NOT overall survival whether it is worth trying anyway??
As I move further on in this cancer experience that I refuse to call a journey I increasingly feel that for me quality of life now rather than endless side effects from debilitating drugs matters more than a few months extra on my life…but I feel it is naughty to even say this.
Jane
Jane,
I think there are many women who use these forums who share your thoughts about quality of life issues and the ghastly side effects from various treatmenrts, but why there is so little discussion about it baffles me, I don’t think you should feel naughty about raising the issue.
I don’t have secondaries and may never have but there’s no way of my knowing for certain at this stage in my cancer experience. So why should I be interested in relping to this thread? I think it is because in my steep learning curve about BC I have realised that the myths about how easily and successfully BC can be treated bear so little reality to actual diagnosis and treatments. In a non BC community there is so little knowledge of recurrence or spread that it came as a shock to me that I could only expect to be found NED and not actually cured. This knowledge started me thinking what I would do if or when cancer returned,
I guess we all make our own decisions and that decision depends in many ways at what stage we are in our lives. I know that if I had been diagnosed with cancer at an earlier age when my children were growing up I would have accepted any drug which would prolong my time with them despite ghastly side effects.
However, since my children are grown up, all partnered and sucessfully living their own lives without me, my priorities have changed. I now want quality in my life.
I’m happy and contented with the life I’ve had and NO I certainly don’t want it to end prematurely but I would think long and hard about enduring ghastly side effects for a few months of denying the inevitable.
These are just my personal thoughts… no intention of offending anyone.
Trish
Jane, Avastin has now received NICE approval {my onc. checked when we were discussing future treatments}. I have been offered it as a possible treatment, but am hanging fire as it requires a brain scan, it does have side effects, and it is very pricey. I am regarding it as something that will be there if things get really bad.
It will be worth discussing with your team what the implications might be. It does appear to have amazing results and if it gives you good time, I would go for it.
This is interesting. I looked up bevacizumab on the NICE website and it still says ‘Expected date of issue: July 2008. 2nd appraisal committee meeting’
Jenny
No didn’t think avastin had got through NICE yet? Where’s the defintive answer?
But what are these ‘amazing results’? Phoebe…again its back to my question about progression free survival v. overall survival? I want more evidence from traials…particularly any which have differentiated triple neg. cnacers.
My onc not mad about avastin for breast cancer…but she’s pretty conservative…I may in future get second opinion at Marsden
Trish: thanks for your thoughts…rather similar to mine.
Jane
I can’t answer where she got this from, but she definitely found it. Personally I am not convinced enough to go that way yet. And I don’t think anything can offer overall survival. It’s a balancing act still and we have to do the balancing.
Hi Phoebe
By overall survival I don’t mean surviving for ever but increasing the amount of time alive…that’s been the test of new drugs in the past.
Agree about the balancing act…and very hard it is to balance at times…
Jane